DRUG
Glepaglutide
Glepaglutide will be delivered in a single-use autoinjector.
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome
Status
Completed
Phase
Phase 3
Enrollment
12
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections. Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Aug 5, 2021
Study start
Aug 10, 2021
Primary completion
Feb 2, 2023
Study completion
Sep 5, 2023
Results posted
Nov 22, 2024
Registry updated
Nov 22, 2024
Outcomes
What the study measures.
Primary outcomes
Change in Absorption of Wet Weight/Fluids
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Secondary outcomes
Change in Absorption of Energy
Time frame · from Week 0 (baseline) to Week 24
Oral intake minus fecal excretion: measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed. Energy absorption was measured by bomb calorimetry.
Change in Absorption of Carbohydrates
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Absorption of Lipids
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Absorption of Proteins
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Absorption of Sodium
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Absorption of Potassium
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Absorption of Calcium
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Absorption of Magnesium
Time frame · from Week 0 (baseline) to Week 24
Measured by 48-hour metabolic balance studies. The metabolic balance study measured the total intake and output of energy, macronutrients (lipids, carbohydrates, proteins) and micronutrients. The oral diet (food and fluids) was assessed by duplicate meals and liquids. During the metabolic balance study, the patients collected duplicate portions of all fluids and liquids covering 24-hour periods. Likewise, all output (ostomy output, diarrhea and urine production) was collected, quantified and analyzed.
Change in Weekly Parenteral Support (PS) Volume
Time frame · from Week 0 (baseline) to Week 12
Only for participants with Short Bowel Syndrome with Intestinal Failure (SBS-IF). PS use was recorded in patient diaries throughout the trial, including type and volume used.
Change in Weekly PS Volume
Time frame · from Week 0 (baseline) to Week 24
Only for participants with SBS-IF. PS use was recorded in patient diaries throughout the trial, including type and volume used.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Age greater than or equal to 18 years and less than or equal to 90 years at screening * Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening. * Stable body weight (less than 5 percent change in weight in the 3 months prior to screening) * Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening Exclusion Criteria: * More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening * Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial * Current bowel obstruction * Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease * Cardiac disease defined as: decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening * Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years * Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening
Study locations
1 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Rigshospitalet
Copenhagen, Denmark
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Glepaglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Efficacy and Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome
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Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS
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Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial
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Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS
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2026-01
Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)
Zealand Pharma · Short Bowel Syndrome
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106
2025-07
A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.
Zealand Pharma · Healthy
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85
2021-07
Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function
Zealand Pharma · Renal Impairment
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2020-11
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
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Related PeptideStat pages
Put the record in context.
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